Robbins Arroyo LLP Announces the Filing of a Securities Fraud Class Action Lawsuit Against Hemispherx Biopharma, Inc.

SAN DIEGO and PHILADELPHIA, Jan. 17, 2013

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The complaint alleges that the Company issued a series of materially false and misleading statements to investors regarding the safety and efficacy of Ampligen®, a drug intended as a treatment for Chronic Fatigue Syndrome.  Specifically, the complaint alleges that Hemispherx misrepresented and failed to disclose that Ampligen did not meet safety and efficacy requirements because its clinical trials were not properly designed.

Hemispherx submitted a New Drug Application to the U.S. Food and Drug Administration ("FDA") for Ampligen in 2007. In 2009, the FDA found that the Phase III study did not adequately support the approval of Ampligen. 

In a July 11, 2012 press release, Hemispherx announced that rather than conducting a new clinical trial, it reached an agreement with the FDA to submit post-hoc analysis of Ampligen for FDA consideration. However, in a meeting held in June 2012 between Hemispherx and FDA officials concerning Hemispherx's ability to gain approval for Ampligen, the FDA noted that "[i]t would be unusual for this type of data to provide adequate evidence of efficacy."

Upon review of the post-hoc analyses, on December 18, 2012, the FDA released a report citing that the additional information submitted by the Company was insufficient. The report further stated that the Company's studies were "ill-defined and invalid," noting inconsistencies regarding the effectiveness and finding nine potential safety concerns. As a result of this news, Hemispherx shares declined $0.276 per share, or approximately 43%, closing at $.368 per share on December 18, 2012.

If you purchased or otherwise acquired Hemispherx stock during the Class Period and wish to serve as lead plaintiff, you must act no later than February 22, 2013.  To discuss your shareholder rights, please contact attorney Darnell R. Donahue at (800) 350-6003, inquiry@robbinsarroyo.com, or via the shareholder information form on the firm's website.